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IMAGE SOURCE: Wikimedia Commons/ gambling chips/ author: Jamie Adams
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Does the Parkinson’s disease drug Mirapex contribute to compulsive gambling?
A federal jury agreed it did and this week awarded $8.2 million to a man who claims the drug caused him to gamble compulsively.
Gary Charbonneau, a retired Milwaukee police officer, says he lost more than $260,000 from compulsive gambling which occurred between March 2002 and February 2006.
Altogether he was prescribed Mirapex (Pramipexole) to treat Parkinson’s for eight years beginning in 1997.
The litigation is the first in a series of more than 307 consolidated lawsuits taking place in U.S. District Court in Minneapolis. Another trial is underway.
Drug makers Pfizer and Boehringer Ingelheim are defendants. They say that the lawsuit conflicts with the FDA’s oversight of prescription drugs. The FDA did not mandate any label changes even though the agency knew about some impulse control issues in some users, drug makers say.
Charbonneau says the drug makers knew the drug caused “intense impulse behavior” but withheld the negative reports and failed to warn doctors or patients.
Boehringer Ingleheim denied any casual link to compulsive behaviors for years, but a complaint filed on behalf of another plaintiff, Robert Hudson, says that the drug makers received many reports of serious gambling and other compulsive behaviors such as compulsive gambling, shopping, porn, eating, and repetitive behaviors, from patients in clinical trials in the mid to late 1990s.
In addition, post-marketing reports of Mirapex patients developing compulsive gambling came in 2002, 2003, and 2004, according to the complaint.
The drug makers said that Charbonneau began gambling “as a matter of choice, not compulsion” and they cited his background of previous gambling.
Information warning doctors and consumers was finally added to the drug insert in 2005, eight years after it was introduced to the market.
“Impulse Control/Compulsive Behaviors
"Cases of pathological gambling, hypersexuality, and compulsive eating (including binge eating)have been reported in patients treated with dopamine agonist therapy, including pramipexole therapy.
"As described in the literature, (p. 12) such behaviors are generally reversible upon dose reduction or treatment discontinuation.”
With the lack of information and a denial of gambling as a potential side effect until 2005, many people just kept taking the drug. More than 10 million prescriptions have been written since the drug was approved, according to Boehringer Ingelheim Pharmaceuticals, speaking to
ABC.
The drug makers also report that patients treated with Mirapex have fallen asleep while operating a motor vehicle and in other daily activities, others experienced hallucinations.
Mirapex is also used to treat restless leg syndrome (RLS) and is sometimes used off-label to treat cluster headaches and low libido from SSRI antidepressant drugs. It is among a class of drugs called “dopamine agonists”- that are believed to stimulate dopamine receptors in the brain.
Dopamine works in the brain’s movement and coordination centers but is also involved in the pleasure response and may be over activating the pleasure centers in an unregulated fashion. When you stop the drug, the behaviors stop. Requip is also in that class and prescribed for Parkinson’s and RLS.
These trials are considered so–called bellwether jury trials that will be used by the remaining potential plaintiff to determine the strength of their cases. Gambling was chosen to be the test as it is the easiest compulsive behavior to calculate damages.
Other causes of action include liability for design, manufacturing and warning; breach of warranty; and negligence.
Those writing to blogs make plenty of jokes about gambling, but others who have taken Mirapex say it’s no joke, “lives are changed forever.” #